Antistatic Compact Space Chamber With Medium Mask

An Anti-Static Compact Space Chamber with a Medium Silicone Face Mask.

Registry build 21.09.26
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NVP
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Respironics Medical Products (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Koo (Shanghai) Industries Co., Ltd. Songjiang Shanghai Contract manufacturer 9

Record

Regulatory record for Antistatic Compact Space Chamber with Medium Mask
Listed by Medical Developments International, Australia
FDA product code NVP
Device type Holding Chambers, Direct Patient Interface
Device class Class 2
Regulation 21 CFR 868.5630
Establishment Manufacturer
Record published 2017-04-13
Record revised 2026-03-06 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number
Storage Handling environment temperature 41 to 104 °F; Handling environment humidity 15 to 95 % RH; Storage environment temperature 41 to 104 °F; Storage environment humidity 15 to 95 % RH
Packaging Outer carton of 24

Catalogue Numbers

Catalogue numbers for Antistatic Compact Space Chamber with Medium Mask
Catalogue number Size Status
SP-ANTI-SMUS In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Aerochamber Plus® Flow-Vu® Monaghan Medical Corp. 23
OptiChamber Diamond Respironics Respiratory Drug Delivery (Uk), Ltd. 8
InspiraChamber Valved Holding Chamber Inspirx, Inc. 8
Aerochamber Plus® Z Stat® Monaghan Medical Corp. 5
Monaghan™ Z Stat® Monaghan Medical Corp. 5
InspiraChamber® Clement Clarke Intl., Ltd. 5
VentiChamber Clement Clarke Intl., Ltd. 5
Clever Choice Simple Diagnostics 3
Flexichamber Avadel Pharmaceuticals (USA), Inc. 2
Breathe Comfort Slv Pharmaceuticals LLC 2
Flexichamber Cerecor Inc. 2
InspiraChamber® Flexicare Medical Ltd. 2

Showing 12 of 38. All products under Holding Chambers, Direct Patient Interface

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K143615 2016-01-26
K122252 2013-11-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer